Fortrea—Regulatory Operations Specialist I

Job description

Description: Job Overview: - Responsible for responsible for managing laboratory instruments, ensuring compliance with regulatory standards, and supporting quality and validation activities in a cGMP environment. Summary of Responsibilities: - Manage the entire lifecycle of laboratory instruments, including installation, qualification, and maintenance. - Oversee the qualification process of new instruments and software, ensuring compliance with internal and external standards. - Prepare and review SOPs, protocols, validation master plans, and other cGMP documentation. - Handle nonconformance reports, initiate change controls, and implement corrective and preventive actions. - Assist in driving digital transformation initiatives within equipment lifecycle management activities - Maintain and update relevant documentation such as VMP, MMP, eCMMS Assets, and Preventive Maintenance schedules. - Conduct data integrity assessments of computerized systems. - Evaluate instrument specifications against USP/EP standards for compliance. - Assist in implementing systems that meet applicable regulatory requirements. - Issue laboratory notebooks and coordinate timely reviews of SOPs and WI. - Support internal and external audits for the department. - Provide support to ECLs in all activities related to equipment lifecycle management. - Escalate the potential issues and serve as analytical strategist and coordinator across the product development stages and post approval maintenance, as applicable. - Management, review and submission of Import/Export Licenses, Dual Use NOC’s and Import Certificates. Responsible for license applications, license availability, debiting and reconciliation, as applicable. - Seek guidance from other team members and manager as needed and keep up to date knowledge of various regulatory guidelines required for pharmaceutical product registration and product life cycle maintenance. - Implement the use of consistent, efficient and quality processes to meet timelines and deliverables according to regulatory requirements, standard operating procedures and maintain a culture of high customer services. - Update and maintain internal and external (client) trackers for metrics, perform and document quality checks, as applicable. - Assist in onboarding, training and mentoring junior staff and perform additional duties as assigned by the manager. - Maintain training related documentation as per Fortrea and client requirements. Qualifications (Minimum Required): - Bachelor’s in pharmacy or related science degree (or equivalent); or advanced degree (e.g., PhD or Masters) with experience of 2-4 years. Fortrea may consider relevant and equivalent experience in lieu of educational requirements.” OR - Bachelor’s degree from Engineering /B.Tech /Packaging /Polymer /Printing stream or Packaging Postgraduate/Diploma/Certification in Packaging with minimum 2-4 years of experience in Packaging field will be preferred. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.” - Speaking-English and/or other languages as applicable. Experience (Minimum Required): - At least 4-7 Years of experience in the job discipline (e.g. Regulatory Affairs/ Quality Assurance/Analytical science / Packaging, polymer and/or printing stream / pharmaceutics / material management and overall drug development and manufacturing process). - Technical proficiency with Microsoft Office suite of applications/ Document Management and/or publishing tools. - Good understanding of the pharmaceutical product life cycle and regulatory requirements, GxP and ICH-GCP guidelines desirable. - Good organizational and time management ability. - Good analytical capabilities and Customer focus. - Good review skills and concern for quality.. Preferred Qualifications Include: - Bachelor’s in pharmacy or related science degree (or equivalent); or advanced degree (e.g., PhD or Masters) with experience of 4-7 years. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.” OR - Bachelor’s degree from Engineering /B.Tech /Packaging /Polymer /Printing stream or Packaging Postgraduate/Diploma/Certification with minimum 4-7 years of experience in packaging field will be preferred. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.” - Knowledge of Management Information System (MIS) and electronic data management system (eg: Regulatory Information Management, etc.) system will be preferred. - Diploma or certification in Regulatory Affairs will be preferred. - Interpersonal skills, Problem solving, Innovation and Proactive, taking ownership, Precise, Goal oriented. - Leadership, problem solving, interpersonal skills. - Excellent analytical skills with the ability to identify process gaps and root causes and develop innovative solutions. - Ability to work independently, meet tight deadlines, and maintain a positive attitude. Physical Demands/Work Environment: - Physical demands: No special factor at this time. - Work environment: Office environment or remote. Learn more about our EEO & Accommodations request here.